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FDA Import Refusal 799-0316120-7/11/1 — Acon Biotech (Hangzhou) Co., Ltd.

Acon Biotech (Hangzhou) Co., Ltd. — FEI 3002829675

The FDA refused shipment 799-0316120-7/11/1 from Acon Biotech (Hangzhou) Co., Ltd. (China) on May 15, 2024. The refused product falls under Devices — CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.. Cited charges: 118,3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 15, 2024
Country
China
Product Category
Devices
Product Code
83QKP CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Charges
118,3280,341

Recent inspections

  • 977049 (NAI Fri May 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-1429805-5/11/1 (Tue Jun 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-0567288-7/11/1 (Mon Aug 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8914461-2/11/1 (Thu Jun 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-1304839-5/11/1 (Thu Jun 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-1404001-1/11/1 (Wed May 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources